GDM: Insulin with or Without Metformin?
ConditionGestational Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Virginia
About this trial
This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
Ability to take oral medication and be willing to adhere to the metformin regimen
Disqualifiers
1) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin + Insulin
DrugPregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.
Insulin
DrugPregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Metformin + InsulinActive comparator 1 intervention
Group B: InsulinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To determine if metformin reduces amount of insulin in patients with gestational diabetes who already require insulin
Insulin dosage (units per kilogram body weight) at last visit prenatal visit
Time frame
From enrollment into study until delivery, maximum 20 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov